EU → North America Device Access

IMPLA srl

IT-MF-000041563 · Italy · Orsenigo

IMPLA srl is registered in the European database on medical devices as a manufacturer, with 40 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa40

Catalogue references include 8310005, 8310006, 8312008, 8312009, 8313000, 8313002.

European nomenclature codes declared: V9099.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED40
Country of registrationItaly

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN40
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. IMPLA srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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